The FDA's take on Biosimilars

3 July 2017

By Dr Nicola Davies

As many first-generation biologics reach the end of their patent life, biosimilars have the potential to bring about much-needed cost savings for the US healthcare system by increasing competition and driving down prices.1,2 However, writes Dr Nicola Davies in her regular exclusive FDA Blog for The Pharma Letter, biosimilar developers must overcome the US Food and Drug Administration’s regulatory requirements to gain access to the world’s largest pharmaceutical market.3

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